General Information. Quidel Contact Information

Transcription

1 User Manual

2 Table of Contents General Information... 3 Quidel Contact Information... 3 Main Menu Structure... 4 Labels and Symbols... 5 Icons... 6 Brief Warnings, Precautions and Limitations... 8 Safety Precautions... 8 Introduction Intended Use Product Description Calibration Check and Quality Control (QC) Development Modes System Components Sofia Additional Ancillaries (optional) User Types System Display System Display Installation, Setup and Operation Sofia 2 Setup Power Up Supervisor Menu Logging in as Supervisor Settings Set Entry Requirements Set Default Mode and Timeout Calibration and QC Data Security Other Settings Network Settings Ethernet Settings LIS Settings Virena Settings Test Virena Connection Statistics View Analyzer Info View Message Log Managing Users Add User Edit User Delete User Export, Import, Delete Export, Import or Delete Data Types Export Settings to USB Flash Drive Import Settings from USB Flash Drive Sofia 2 Firmware and Assay Methods Import Firmware from USB Flash Drive Import Assay Methods from USB Flash Drive Page 1 of 42

3 Import Language Files from USB Flash Drive Run Test (Patient Specimens) Enter the User ID Enter the Patient ID Enter the Order Number, if applicable Change Development Mode Test Procedure Press Patient Test Results Review Data Review Patient Results Review QC Results Review Calibration Results View Lot Status View Assay Methods Run QC QC Results Run Calibration Perform Sofia 2 Calibration Check Calibration Results Send Data Shutdown Maintenance and Cleaning Maintenance Battery Power Cleaning Appendices Appendix A Technical Specifications Sofia Appendix B System Troubleshooting Error Messages Page 2 of 42

4 General Information Quidel Contact Information Contact Quidel Technical Support from 7:00 a.m. to 5:00 p.m. Pacific Time Tel: (in the U.S.); (outside the U.S.) Fax: or contact your local distributor Website: quidel.com Page 3 of 42

5 Main Menu Structure Page 4 of 42

6 Labels and Symbols Label/Symbol Description Manufacturer In vitro diagnostic medical device Consult instructions for use Authorized representative in the European Community Temperature limitation Humidity limitation Waste electrical and electronic equipment (WEEE) Serial Number Catalog Number Warning / Caution Ultraviolet Radiation Potential Biohazard Page 5 of 42

7 Icons Page 6 of 42

8 Page 7 of 42

9 Brief Warnings, Precautions and Limitations Always operate Sofia 2 on a surface that is level, dry, and not in direct sunlight. The Sofia 2 Calibration Cassette is sensitive to light. Store it in the opaque sleeve whenever it is not being used. Do not write on the barcode or surface of the Cassette. Never move Sofia 2 or open drawer while there is a test in progress. Use only the Power Adapter that was provided with Sofia 2. Do not drop Sofia 2 as it could damage the unit. To avoid damaging Sofia 2, do not place objects on top of it. Contact Technical Support if the instrument is damaged. Sofia 2 has been designed to CISPR 11 Class A. In a domestic environment, it may cause radio interference, in which case you may need to take measures to mitigate the interference. Safety Precautions Sofia 2 is designed to provide safe and reliable operation when used according to this User Manual. If Sofia 2 is used in a manner not specified in the User Manual, the protection provided by the equipment may be impaired. All warnings and precautions should be followed in order to avoid unsafe actions that could potentially result in personal injury or damage to the device. Warning! To reduce the risk of electrical shock: Unplug Sofia 2 before cleaning. Plug the device into an approved receptacle. Do not immerse in water or cleaning solutions. Do not attempt to open the enclosure. Ultraviolet Radiation! To reduce the risk of UV Exposure: Do not attempt to open or disassemble Sofia 2. Do not attempt to look inside Sofia 2 while operating. Failure to follow these warnings will invalidate the warranty. Page 8 of 42

10 Potential Biohazard! To reduce the risk of biohazard: Dispose of used specimens in accordance with Federal, State and Local requirements. Treat specimens and patient samples as potentially biohazardous material. Ensure Sofia 2 is cleaned per the Maintenance and Cleaning section. Seek specific training or guidance if you are not experienced with specimen collection and handling procedures. Use of Nitrile, Latex, or other gloves is recommended when handling patient samples. Caution! To reduce the risk of incorrect results: Sofia 2 should only be used by trained operators. Do not use if Sofia 2 is reporting an error condition that cannot be corrected. To obtain accurate results, refer to the assay-specific Package Insert for details on specific tests. Use the test kit within the expiration date. To reduce the risk of Sofia 2 damage: Sofia 2 is designed for counter top operation. Sofia 2 is not designed to withstand moisture, extreme humidity, or extreme temperatures. Sofia 2 is not designed to withstand severe shock or vibration. Do not open or disassemble the device. Failure to follow the precautions mentioned above will invalidate the warranty. To reduce the risk of environmental contamination: Contact Quidel Technical Support at for return or disposal of Sofia 2. See page 3 for additional contact information. Clean Sofia 2 per the Maintenance and Cleaning section of this User Manual prior to return or disposal. Sofia 2 must be disposed of in a safe and compliant manner. Applicable Federal, State and Local regulatory requirements shall be followed to ensure Sofia 2 is not disposed of as municipal waste. If you are unsure on the proper methods for disposal, contact a certified waste broker for guidance. Note: Medical equipment that may have come into contact with potentially infectious materials (e.g., patient samples, blood, serum, etc.) must be properly decontaminated prior to disposal or recycling. Page 9 of 42

11 Introduction Intended Use Sofia 2 is a bench top analyzer intended to be used with Cassette-based immunofluorescent in vitro diagnostic assays manufactured by Quidel Corporation. Sofia 2 is intended for professional and laboratory use. Rx Only After the patient sample has been added to the Test Cassette, depending upon the User s choice, the Test Cassette is either placed inside of Sofia 2 for automatically timed development (WALK AWAY Mode) or placed on the counter or bench top for a manually timed development and then placed into Sofia 2 to be read (READ NOW Mode). Sofia 2 will read the test strip and measure the fluorescent signal by processing the results using method-specific algorithms. Sofia 2 will display the test results. Refer to assay-specific Package Insert for details on specific tests. Product Description Sofia 2 uses a fluorescent tag that is illuminated by an Ultraviolet (UV) light source to generate specific results. In each test, an internal procedural control line is also read. This ensures that sample flow has occurred within the Test Cassette to permit an accurate reading. Sofia 2 then displays the test results to the User on the screen and automatically saves them on the device. If configured, the results may also be sent to an attached printer or stored in the cloud using Virena. Calibration Check and Quality Control (QC) Sofia 2 Calibration Check and External Quality Control Tests must be performed on a periodic basis. Sofia 2 Calibration Check: Calibration Check is a required function that checks the internal Sofia 2 optics and systems. A Calibration Check must be performed every 30 days or less. A special Calibration Cassette is provided with Sofia 2. For replacement Calibration Cassettes, contact Quidel Technical Support. External Quality Controls: Refer to assay-specific Package Insert for details on specific tests. Instructions are provided in the Run Calibration and Run QC sections. Page 10 of 42

12 Development Modes When a patient sample is added to the Test Cassette, it begins to flow through the test strip. The development time required varies by test type. Refer to the assay-specific Package Insert to determine the required development time of each test, and the required storage conditions of the test and external controls. The correct development time is required to get accurate results. Sofia 2 has been designed to operate in different development modes. The Supervisor and User can identify the mode that works best with their workflow and testing volume. WALK AWAY Mode may be the most convenient for reading a single patient sample, as the User can walk away during the development period. Sofia 2 has the capability of two different WALK AWAY Modes: User-selected WALK AWAY Mode and LOCKED WALK AWAY Mode. User-selected WALK AWAY Mode may be the most convenient for reading a single patient sample, as the User can walk away during the development period. In this mode, the User dispenses the patient sample into the Test Cassette and then immediately inserts the Test Cassette into Sofia 2. Sofia 2 will automatically allow the Test Cassette to develop for the required time period (pre-programmed for each test), read the Test Cassette, analyze and interpret the data, and automatically and objectively display the test result. Depending on the test, Sofia 2 may also read the Test Cassette periodically during the development time and display a positive result prior to the final test time. LOCKED WALK AWAY Mode can only be selected while logged in as a Supervisor. In this mode, Sofia 2 has been locked into WALK AWAY development timing for ALL assays run on the analyzer. READ NOW development timing will not be available when this Default Mode has been selected. READ NOW Mode may be most convenient for high volume situations as Sofia 2 can quickly read multiple patient samples sequentially. The User dispenses the patient sample into the Test Cassette. The User then manually times the development period outside of Sofia 2. This can be done on the counter or bench top using a timer. Refer to the assay-specific Package Insert for the required development time. Once the development time is complete, the User inserts the Test Cassette into Sofia 2. Sofia 2 will immediately read and display the test result within 1 minute. System Components The following system components are supplied with Sofia 2: Sofia 2 Sofia 2 with Rechargeable Battery Power Adapter QuickStart Guide Calibration Cassette Page 11 of 42

13 Additional Ancillaries (optional) Dymo LabelWriter 450 Printer (Part # ) Dymo Vinyl Label Roll, 2 5/16 x 4 (Part #30256) Replacement Battery Contact Quidel Technical Support for additional supplies at (in the U.S.). See page 3 for additional contact information. Sofia 2 consumable test kits, including Test Cassettes and External Quality Control materials, are supplied separately. Consult your Quidel representative for a listing of approved Sofia 2 assays. User Types Users without Supervisor authorization have access to the following functions: User/Operator Power on Sofia 2 Perform Calibration Run QC (External Controls) Run Test with Patient Samples Review Data (Patient, Calibration and QC) Users with Supervisor authorization access can perform all of the following functions: Supervisor (Must have a valid log-in to access Supervisor Menu.) Import Assay Methods Add or Delete Users Export and Import Settings Update Sofia 2 Firmware Import Language Files View Message Logs Review Statistics Change Settings Page 12 of 42

14 System Display System Display Sofia 2 contains a 4-inch color LCD display for interacting with the user interface (Figure 1). Figure 1 Touchscreen Display Barcode Scanner Cassette Drawer Installation, Setup and Operation Sofia 2 Setup Place Sofia 2 on the bench top. The unit is portable and can be moved to a suitable location for testing. Ensure counter top is stable, level, dry and free of obstructions. Avoid direct sunlight. Ensure the bench provides adequate space for Sofia 2. There must be space to open/close the Sofia 2 drawer and access the connection ports on the back of the unit. Plug the Power Adapter into the power port on the back of Sofia 2. Then plug the Adapter into an available electrical outlet. If using the optional Dymo Label Printer, connect to Sofia 2 by plugging into a USB port on the back of the instrument (Figure 2). Page 13 of 42

15 Power Up Turn Sofia 2 on using the power switch located on the rear panel (Figure 2). Figure 2 Power Switch Battery Compartment USB Ports (2) RJ45 Power Port Sofia 2 will display the Power On Progress screen and complete a Power On Self-Test. Once the Power On is complete, Sofia 2 will display the Run Test screen (Figure 3) and it is ready for use. Figure 3 When turning on Sofia 2 for the first time, Sofia 2 will prompt the user to enter the ZIP Code where it is located (Figure 4). Select to confirm and continue to the next screen. Page 14 of 42

16 Figure 4 A Calibration Check must also be performed before using Sofia 2 for the first time (Figure 5). The default Supervisor ID (1234) will be used for the Calibration Check. Figure 5 Supervisor Menu Page 15 of 42

17 Logging in as Supervisor The Supervisor Menu allows the Supervisor to access additional functionality and security options depending on the work environment and the location of Sofia 2. Settings Entry to the Settings menu is accomplished by logging in as the Supervisor. Sofia 2 comes from the manufacturer with a default Supervisor login ID which should be changed when Sofia 2 is initially installed at the customer site. The default Supervisor ID is Note: If the factory default ID is deleted and all other Supervisor codes have been misplaced or forgotten, please call Quidel Technical Support for a 1-day temporary Supervisor ID code that will allow the User to create a new Supervisor ID code. Contact Quidel Technical Support for assistance at (in the U.S.). See page 3 for additional contact information. Set Entry Requirements Setting the Entry Requirements allows the Supervisor to control what information is provided before running a test. Note: User ID and Order Number can be set to Required or Optional. Patient ID can be set to Required, Optional or Disabled. When set to Required, the fields must be entered for the User to run a patient test. When the Entry Requirements are complete, continue to Set Default Mode and Timeout using. Set Default Mode and Timeout Default Mode When the Supervisor sets Sofia 2 to a certain default mode, this will be the normal operating mode unless otherwise changed. Select either WALK AWAY, READ NOW or LOCKED WALK AWAY development mode. Idle ID Timeout The Idle ID timeout sets the amount of time that a User ID remains entered and active as a User in running various tests and activities. After the timeout period has expired, the User must re-enter their ID number. Using the on-screen keypad, enter the number of minutes for the timeout from Press to confirm when changes are complete to return to the Run Test screen. Calibration and QC Calibration Reminder Using the on-screen keypad, enter the number of days for the Calibration reminder interval from When the selected number of days remain until required Calibration, the Page 16 of 42

18 reminder will appear next to the menu icon on the Run Test screen. Press to confirm when changes are complete to return to the Run Test screen. Data Security The Data Security screen allows the Supervisor to select the number of patient results that remain stored on Sofia 2. The Supervisor may also choose whether patient data is saved along with test data to an attached USB flash drive. In the Stored Patient Data field, use the on-screen keypad to enter the number of patient results saved on the device from In the Save Patient Data to USB field, select On or Off. If set to On, patient data will be saved along with test records when exporting to an attached USB flash drive. A USB flash drive must be attached prior to beginning a test for that result to be saved. Press to confirm when changes are complete to return to the Run Test screen. Other Settings Set Site Name and ZIP Code The Site Name and ZIP Code settings set the name and location of the clinic, hospital, lab or physician s office where Sofia 2 is being used. In the field for Site Name, use the on-screen keypad to enter the location name up to 20 characters and/or spaces. To delete a letter, press on the keypad. Pressing setting. at any time cancels the changes and returns the Site Name to the previous In the field for ZIP Code, use the on-screen keypad to enter the 5-digit ZIP Code. The ZIP Code entered for the facility in MyVirena must be used to successfully configure Virena as described on page 19. When the Site Name and ZIP Code are complete, continue to Set Sound using. Set Language Sofia 2 can be set to display languages which were previously installed from the Export, Import, Delete menu (page 27). Use or to select the appropriate language. This language will be displayed once the user returns to the Run test screen. When the Language is set, continue to Set Sound. Page 17 of 42

19 Set Sound Setting the Sound on Sofia 2 will allow the Supervisor to turn on or off the beep sound for notifications or when a barcode is scanned. When the Sound is set, continue to set Time and Date using. Set Time and Date The Time option allows for two different time formats to suit specific country requirements. The User can change the displayed time format to 12h or 24h format. In the field, select either 12h or 24h. Use the on-screen keypad to enter the correct time. When the 12h format is selected, also select AM or PM. When the 24h format is selected, the AM/PM buttons are non-functional. If an invalid time is added, the field will highlight in red and the will not be available. The Date option allows for two different date formats to suit specific country requirements. In the field, the User can select the date format as either mm/dd/yy or dd/mm/yy format. Use the on-screen keypad to enter the correct date. If an invalid date is added, the field will highlight in red and the will not be available. Press to confirm when changes are complete to return to the Run Test screen. Network Settings Ethernet Settings For Set IP Address, select Manual or DHCP. If DHCP is selected, select to test the connection and return to the Run Test screen. If Manual is selected, press to continue to the next screen. Using the on-screen keypad, enter information for IP Address, Subnet Mask, and Gateway. Press to continue to the next screen. Using the on-screen keypad, Page 18 of 42

20 enter the information for Primary DNS and Secondary DNS. Select and return to the Run Test screen. to test the connection LIS Settings Use the on-screen keypad to enter LIS IP Address. LIS Port is pre-populated and no additional user input is needed (Figure 6). Figure 6 Press to continue to the next screen. For Auto Send, select either On or Off. If set to On, test results will automatically be sent to the LIS as tests are run. If set to Off, test results will need to manually be sent to the LIS if desired. See the Send Data section on page 34 for additional information. Select to confirm configuration and return to the Run Test screen. Virena Settings Before configuring Virena, ensure that the correct ZIP Code has been entered upon initial startup or in the Other Settings menu. See page 17 for additional information. On the first Virena Settings screen, Virena Domain Name is pre-populated and no additional user input is needed (Figure 7). Figure 7 Press to continue to the next screen. For Auto Send, select either On or Off. For Queue Results, select either On or Off (Figure 8). Both settings must be set to On to send results to the Virena cloud daily. Upon activation of Sofia 2 s network capabilities, Sofia 2 will transmit Page 19 of 42

21 data, de-identified in accordance with 45 C.F.R (b)(1), from the customer s Sofia 2 to Quidel s network of secured, third-party remote hosted servers. Figure 8 Press to continue to the next screen. For Transmit Patient ID, select either On or Off. For Transmit Order Number, select either On or Off (Figure 9). This information is used for study purposes only and this information will not be transmitted regardless of the selection. Figure 9 Press to continue to the next screen. For Age Required, select either Yes or No (Figure 10). If set to Yes, the User will need to enter the patient s age prior to running each test. For Connection Interface, select either Ethernet or Cellular. If set to Ethernet, the User will also need to configure Ethernet Settings. See page 18 for additional information. Figure 10 Page 20 of 42

22 Select to confirm configuration and return to the Run Test screen. Test Virena Connection The final step of Virena configuration is to test the connection. This is accessed through the Send Data screen (page 34). Select Test Connection and press to begin the connection test (Figure 11). If successful, the on-screen pop-up will display Test connection success. If unsuccessful, the on-screen pop-up will display Test connection error. If the connection test is unsuccessful after a second attempt, please contact Quidel Technical Support. Figure 11 Statistics View Analyzer Info The first screen of View Analyzer Info displays the Firmware Version, Hardware Version, Number of Tests, and Serial Number (Figure 12). Select to continue to the next screen or to return to the Run Test screen. Page 21 of 42

23 Figure 12 The second screen of View Analyzer Info displays the Ethernet MAC, WiFi MAC, Cellular Firmware Version, IMEI, and ICCID (Figure 13). Select to return to the Run Test screen. Figure 13 View Message Log View Message Log displays the Error Code, Date and Time (Figure 14). Select to return to the Run Test screen. Figure 14 Page 22 of 42

24 Managing Users Add User To add a User, Select on the Add User screen (Figure 15). Use the on-screen keypad or barcode scanner to enter the User ID. User ID must be at least 4 digits. Choose User Type by selecting Operator or Supervisor. Enter the Name for the new User using the on-screen keypad. To delete a letter, press on the keypad. Pressing setting. at any time cancels all previous changes and returns the Name to the previous When the name is complete, press. Page 23 of 42

25 Figure 15 Edit User Select a User by touching anywhere within the row, then select keypad to edit the User information (Figure 16).. Use the on-screen Figure 16 When the information is complete, press. Delete User Select a User by touching anywhere within the row, then select to delete User (Figure 17). This action cannot be undone. If a User is deleted by mistake, re-add the User as described above. Page 24 of 42

26 Figure 17 Note: Maximum number of Users is 100. Export, Import, Delete Export, Import or Delete Data Types Supervisors may export, import or delete data to/from either a USB flash drive or the device (Figure 18). Most standard USB flash drives may be used with Sofia 2. Figure 18 Page 25 of 42

27 Export Settings to USB Flash Drive Supervisors may export the settings of one Sofia 2 to import to another Sofia 2. Use the or in the first field to select Export. In the next field, use or to select Settings. Insert a USB flash drive and select, then select to export Sofia 2 settings data. Once complete, it is safe to remove the USB flash drive. When cloning Sofia 2, all Users will transfer over. User history, lot status, QC and test data will not transfer over. Import Settings from USB Flash Drive To import the settings of one Sofia 2 onto another Sofia 2, insert the USB flash drive from the Master Sofia 2 that has the settings you wish to duplicate. Use or in the first field to select Import. In the next field, use or to select Settings. Ensure that is selected, then select to import Sofia 2 settings data. Once complete, it is safe to remove the USB flash drive. Note: When importing settings from one Sofia 2 to another, patient and QC results on the incoming Sofia 2 will be deleted. Sofia 2 Firmware and Assay Methods Occasionally, Quidel may release firmware and assay method updates to improve functionality of Sofia 2. Users can ensure that their Sofia 2 has the most current firmware and assay methods by enrolling for an account and registering their Sofia 2 at myquidel.com. By following the instructions on the site, Supervisors may install updates from a USB flash drive. Additional detail can be found at myquidel.com. Import Firmware from USB Flash Drive Insert USB flash drive with the firmware to install. Use or in the first field to select Import. In the next field, use or to select Firmware. Ensure that is selected, then select to import Sofia 2 firmware. Sofia 2 will complete a self-installation and then power up in the normal startup screen. Once complete, it is safe to remove the USB flash drive. Page 26 of 42

28 Import Assay Methods from USB Flash Drive Insert USB flash drive with the assay method to install. Use or in the first field to select Import. In the next field, use or to select Assay Methods. Ensure that is selected, then select to import Sofia 2 assay methods. Sofia 2 will complete a self-installation and return to the previous screen. Once complete, it is safe to remove the USB flash drive. Import Language Files from USB Flash Drive Insert USB flash drive with the language file to install. Use or in the first field to select Import. In the next field, use or to select Language Files. Ensure that is selected, then select to import Sofia 2 language files. Sofia 2 will complete a self-installation and return to the previous screen. Once complete, it is safe to remove the USB flash drive. Run Test (Patient Specimens) The Run Test screen can also be accessed by selecting Enter the User ID on most screens. User ID can be entered using the barcode scanner or manually using the on-screen keypad. Select the User ID field on the Run Test screen. Use the barcode scanner (Figure 19) to scan the barcode from a User s ID Card or manually enter the data using the on-screen keypad on Sofia 2. Enter the Patient ID Patient ID can be entered using the barcode or manually using the on-screen keypad. Page 27 of 42

29 Select the Patient ID field on the Run Test screen. Use the barcode scanner (Figure 19) to scan a Patient ID barcode from a patient chart or other source or manually enter the data using the on-screen keypad on Sofia 2. Figure 19 Enter the Order Number, if applicable Order Number can be entered using the barcode or manually using the on-screen keypad. Select the Order Number field on the Run Test screen. Use the barcode scanner to scan an order number barcode from a patient test requisition or other source or manually enter the data using the on-screen keypad on Sofia 2. Change Development Mode Select the desired Development mode: WALK AWAY or READ NOW (See description of the WALK AWAY and READ NOW development modes on page 11). IMPORTANT: Refer to the assay-specific Package Insert for each specific test for instructions on preparing Test Cassettes with patient samples. The current development mode will be highlighted below the Order Number field (Figure 20). If the highlighted mode is the desired mode, no changes are required. Figure 20 Page 28 of 42

30 Test Procedure In the WALK AWAY development mode, proceed directly to the next steps as soon as the patient specimen has been processed and added to the Test Cassette. Do not let the Test Cassette develop outside Sofia 2. In the READ NOW development mode, remember to first manually time the test development of the patient specimen Test Cassette outside of Sofia 2 at room temperature for the required period of time (as defined in the assay-specific Package Insert) before proceeding to the next step. To access additional detail on the two development modes from the Run Test screen select. To return to the Run Test screen from the pop-up, select. Press After ID information is entered and development mode is selected, press the next screen. to advance to If Virena has been configured, the User will advance to the Patient Information screen where additional patient information may be entered. If Age Required has been set to Yes, the User will be asked to enter the patient s age before advancing. Refer to the Virena Settings section on page 19 for more information. Press to advance to the next screen and gently pull open the Sofia 2 drawer. Note: If Virena is not configured, the User will advance directly to the insert cassette screen after pressing. Insert the Test Cassette into the drawer and gently close the drawer (Figure 21). Figure 21 Page 29 of 42

31 Upon closing the drawer, Sofia 2 will start automatically and display the progress on the screen. Patient Test Results When the test is complete, the results for both the patient specimen test(s) and for the internal procedural control will be displayed on the Sofia 2 screen and automatically saved on the device. If configured, results may also be stored in the cloud using Virena or transmitted to the LIS. The results may be also be printed on an attached printer by selecting. Refer to the assay-specific Package Insert for details on how to interpret results for specific tests. Note: Once results have been generated for an individual Test Cassette, Sofia 2 will no longer accept that Cassette a second time. If the procedural control is, repeat the test with a new patient sample and a new Test Cassette. To run another patient specimen, select to return to the Run Test screen. Review Data Review Patient Results Patient Results include the records for previously run patient tests. In any list of Patient Results, you may show the detailed results by selecting the result to view (Figure 22). Page 30 of 42

32 Figure 22 Select to return to the Run Test screen. Review QC Results QC Results include the records for previously run QC (Positive and Negative Control) tests. The operator is able to locate QC result details in the same manner as Patient Test Results (Figure 23). Figure 23 Select to return to the Run Test screen. Review Calibration Results Sofia 2 Calibration Results include the records for previously run Calibration tests. A list of the Calibrations performed will be displayed (Figure 24). Page 31 of 42

33 Figure 24 Select to return to the Run Test screen. View Lot Status QC Lot Status QC Lot Status displays the QC Kit/Lots of assays and their expiration dates. This information is captured by Sofia 2 when Quality Controls are run. A list of the Kit/Lots that have been processed by the QC procedure will be displayed along with the expiration date. Select to return to the Run Test screen. View Assay Methods A list of the installed Assay Methods and Version number loaded is displayed. Select Run QC to return to the Run Test screen. External Quality Control (QC) may be tested to demonstrate that the assay-specific reagents, Test Cassettes and assay procedures are performing properly. Page 32 of 42

34 To run the External Controls, refer to the assay-specific Package Insert for each specific test for step-by-step instructions. Note: When running Positive and Negative controls with a qualitative test, the Positive Control must be tested first before the Negative Control. QC Results Once the QC run is complete, the system will display either a valid result, result,., or an invalid Select to complete the QC process and return to the Run Test screen. If the QC controls do not pass, repeat the external control testing process or contact the Supervisor or Quidel Technical Support at (in the U.S.) for assistance before testing patient specimens. See page 3 for additional contact information. Run Calibration Calibration Check is a required function that ensures optimal performance by checking the internal Sofia 2 optics and functions. IMPORTANT: Calibration Check must be performed within 30 days, prior to testing any patient sample. Refer to the assay-specific Package Insert for Calibration Check frequency. Perform Sofia 2 Calibration Check Use the specific Calibration Cassette included with Sofia 2 for the Calibration Check. For replacement Calibration Cassettes, please contact Quidel Technical Support. Following the prompts, insert the Calibration Cassette into Sofia 2 and gently close the drawer. Sofia 2 will perform the Calibration Check automatically. Select to return to the Run Test screen after Calibration is completed. Page 33 of 42

35 Calibration Results Caution: Store the Calibration Cassette in the provided storage pouch at room temperature (15 C to 30 C) between uses. Improper storage could damage the Calibration Cassette, which may lead to failed Sofia 2 Calibration Check. Do not touch the read window of the Calibration Cassette as this may impact the results. Sofia 2 displays results as either or indicating that Calibration Check is completed. The Calibration results are stored and can be recalled with the Review Calibration Results function of Sofia 2 from the Review Data menu (page 32). Note: If Calibration Check does not complete successfully, notify the on-site Supervisor or contact Quidel Technical Support for assistance at (in the U.S.). See page 3 for additional contact information. Send Data For Send Data, the following options will be displayed on the screen: Last Result All Results Test Connection To manually send data to Virena, select one of the options above then press. If data was sent successfully, will appear on the screen. If data was not sent successfully, the message Send To Virena Error will appear. Confirm Virena configuration and re-attempt to send data. If unsuccessful after a second attempt, contact Technical Support. To manually send data to the LIS, select one of the options above then press. If data was sent successfully, will appear on the screen. If data was not sent successfully, the message Send To LIS Error will appear. Confirm configuration and re-attempt to send data. If unsuccessful after a second attempt, contact Technical Support. Page 34 of 42

36 Shutdown Turn off the unit by holding the power switch in the rear of the unit. Shutdown is complete when the screen goes dark. Maintenance and Cleaning Maintenance Note: Sofia 2 must be sent to Quidel if maintenance is required. The User should not attempt any maintenance except for changing the battery and cleaning the external surfaces and Cassette drawer. Battery Power Battery Intended Use Sofia 2 includes a rechargeable battery. The battery will automatically charge while plugged into AC power. Sofia 2 will automatically switch to battery power when AC power is not available. Battery Replacement Sofia 2 is shipped with an internal LiPo rechargeable battery with an expected life of approximately three years. Use only a Quidel-supplied Sofia 2 replacement battery. To optimize instrument performance and charging, it is recommended that the battery remain installed in the instrument. Prior to replacing the battery, ensure that there is no cassette in Sofia 2. Then power down and unplug Sofia 2. Remove the battery cover on the rear of the instrument. Disconnect the battery cable and carefully slide out the battery (Figure 25). Attach the new battery and replace the battery cover. Recycle or dispose of the lithium battery in accordance with all Federal, State and Local laws. To avoid fire and explosion hazard, do not burn or incinerate the battery. Batteries shall not be disposed of with municipal waste. Page 35 of 42

37 Figure 25 Cleaning To reduce the risk of electrical shock: Do not disassemble Sofia 2. Sofia 2 contains no user serviceable components. Possible electrical shock: Turn off and unplug Sofia 2 prior to cleaning. Do not clean the ports on the back of the instrument. Do not immerse or spray Sofia 2 in liquid. Do not clean the underside of the instrument. Turn off and unplug Sofia 2 before cleaning. Use a soft cloth with 70% alcohol or 0.6% bleach solution to clean exterior of Sofia 2. Do not use soap or other solutions except those noted below. Wipe the external surfaces and cassette drawer only. Note: The following disinfectants identified in EPA s list of disinfectants for use against Ebola virus have been found by Quidel to be compatible for use with Sofia 2: Clorox Healthcare; Bleach Germicidal Cleaner (EPA Reg #: ) Clorox Commercial Solutions; Clean-Up Disinfectant Cleaner with Bleach 1 (EPA Reg #: ) Clorox Healthcare; Bleach Germicidal Wipes (EPA Reg #: ) Removing the Drawer for Cleaning Ensure that there is no cassette in the drawer and unplug Sofia 2. Gently pull drawer out until it stops, then lift up Sofia 2 and press the button as shown (Figure 26). The drawer can then be removed. Note: If resistance is met, do not force. Apply slightly more pressure to release the catch. Page 36 of 42

38 Figure 26 Use a soft cloth with 70% alcohol or 0.6% bleach solution to clean the drawer only. Do NOT clean the interior of Sofia 2. Do NOT submerge drawer in cleaning solution. After cleaning the drawer, insert it carefully aligning the rails of the drawer into the tracks of Sofia 2 (Figure 27). Figure 27 Gently slide the drawer until it is latched closed. If resistance is met or the drawer does not slide easily, check the alignment of the rails in the track. Go to the Main Menu and perform Calibration. Page 37 of 42

39 Appendices Appendix A Technical Specifications Sofia 2 Dimensions Weight Power Supply Input 22 cm deep x 12 cm wide x 12 cm high 2 lbs (1 kg) VAC, 50/60 Hz, self-switching (U.S./International), 2.93 Amp maximum Sofia 2 Input 7.5V DC 2.5A Replaceable Battery Display LAN Interface LiPo rechargeable battery 4-inch color LCD touchscreen RJ45 connector Operating Temperature 15 C to 30 C / 59 F to 86 F Operating Humidity Operating Altitude Shipping and Storage Temperature Shipping and Storage Humidity Patient Test Result Storage QC Results Storage Calibration Results Storage User Storage 20% to 85% RH non condensing 2000 m maximum 20 C to 55 C 20% to 85% RH non condensing 1,000 tests maximum 200 results maximum 200 results maximum 100 users maximum Page 38 of 42

40 The following barcodes have been configured at time of shipment: 1D Barcodes: UPC-A CODE 11 UPC-E CODE 39 EAN 13 WITH EXTENDED COUPON CODE CODE 93 AND 93i CODABAR CODE 128 INTERLEAVED 2 OF 5 GS1 DATABAR IATA CODE 2 OF 5 MSI 2D Barcodes: DATA MATRIX AZTEC CODE QR CODE Appendix B System Troubleshooting Error Messages Note: The chart below describes the error messages that may be displayed while using Sofia 2. If unable to resolve the problem after troubleshooting, please record the error message and contact Quidel Technical Support. The error message will help Technical Support diagnose the problem. ID Displayed Text Action 1 Unexpected error. Contact Technical Support. 2 User ID must be entered. Enter a valid User ID to proceed. 3 Patient ID must be entered. Enter a Patient ID to proceed. 4 Invalid User ID. Enter a valid User ID to proceed. 5 Removable storage is missing or not Insert a USB flash drive. writable. Please insert a USB storage device and try again. 6 Kit Lot ID must be entered. Enter the Kit Lot number. 7 File write failed. Replace USB flash drive. 8 Current temperature out of range of assay or system. Temperature range allowed is 15 C to 30 C / 59 F to 86 F. 9 Printing error. Check connection to printer. 10 Invalid QC Card barcode. Check or rescan QC Card. 11 Printer not found. Check connection to printer. Page 39 of 42

41 ID Displayed Text Action 12 Unreadable Cassette barcode. Ensure Cassette is inserted properly and there are no markings on the barcode. 13 Cassette not valid for current test. Retest using a Cassette of the correct device type. 14 Assay Method File unavailable for Only test with approved Sofia 2 assays. supplied Cassette. 15 Cassette cannot be reused. Use a Test Cassette that has not been previously run. 16 Cassette drawer is open, unable to read Close drawer to proceed with test. barcode. 17 Barcode scanning in progress. Wait until barcode scan is complete. 18 Cassette is past the expiration date. Retest with a non-expired Cassette. Please retest with a non-expired Cassette. 19 Calibration period has expired and the Calibrate Sofia 2. instrument is locked until Calibration has been successfully completed. 20 Cassette barcode is invalid, missing or unreadable. Retest using a Cassette with a valid barcode. 21 Data could not be successfully exported. Confirm correct USB flash drive was used and inserted correctly. 22 Data could not be successfully imported. Confirm correct USB flash drive was used and inserted correctly. 23 User ID already exists. Choose another User ID. 24 QC Card is past the expiration date. Retest with a non-expired QC Card. 25 There was an error performing the upgrade. Please reboot and try again. Confirm correct USB flash drive was used and inserted correctly. 26 User Name contains invalid characters. Enter a User Name containing 20 characters or less. 27 Language file could not be successfully loaded. Confirm correct USB flash drive was used and inserted correctly. 28 Loading Assay Method failed. Confirm correct USB flash drive was used and inserted correctly. 29 Log file could not be successfully exported. Confirm correct USB flash drive was used and inserted correctly. 30 Battery is low. Please plug in to AC power before running another test. Connect Sofia 2 to AC power or charge battery before running another test. 31 Calibration Failed. Contact Technical Support. 32 Power On Self-Test error. Clean the drawer, including the two chips located on either side of the drawer, re-boot instrument and retry. If not corrected, Page 40 of 42

42 ID Displayed Text Action discontinue use and contact Technical Support. 33 Supervisor ID should have between 4- Check Supervisor ID and re-enter. 12 characters. 34 Last Supervisor cannot be changed. Create a replacement Supervisor or set a new default Supervisor before changing User status. 35 Stray light or wrong Calibration. Restart Sofia 2 and if issue continues, contact Technical Support. 36 Invalid Operator Number. Enter a valid Operator number (i.e., is not a duplicate or longer than 20 digits). 37 Logged-in User cannot be deleted. Log out User and log in as another User before deleting. 38 Logged-in User cannot be changed to an Operator. Log out User before changing User status. 39 Mains power must be supplied to upgrade. Please plug in to AC power and try again. 40 USB storage device does not contain a valid upgrade file. Connect Sofia 2 to AC power before upgrading firmware. Ensure that correct firmware upgrade file has been downloaded from myquidel.com. Confirm correct USB flash drive was used and inserted correctly. Confirm correct USB flash drive was used and inserted correctly. 41 There was an error performing the upgrade. Please reboot and try again. 42 Removable storage is missing. Please insert a USB storage device with the upgrade file and try again. 43 User ID and Operator Number must not Enter a PIN that is different from the match. Operator Number. 44 User rights are insufficient for this Log in as a Supervisor to access this function. function. 45 Test connection error. Contact Technical Support. 46 Unable to apply settings changes, Return to Settings screen an attempt to previous values retained. apply changes again. 47 Send to Virena error. Contact Technical Support. 48 Invalid age. Enter an age between Invalid study code. Enter a study code containing 1-2 numeric characters. 50 Send to Virena error. Battery is faulty. Contact Technical Support. 51 Restore factory defaults error. Contact Technical Support. 52 The operation failed to produce a result. Contact Technical Support. Page 41 of 42

43 ID Displayed Text Action 53 USB storage device does not contain Assay Methods. Ensure that correct Assay Method File has been downloaded from myquidel.com. 54 Some files were not imported successfully Sofia 2 Ensure that correct files have been downloaded from myquidel.com. MDSS GmbH Schiffgraben Hannover, Germany Quidel Corporation McKellar Court San Diego, CA USA quidel.com EN00 (08/18) Page 42 of 42